We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Acting FDA Commissioner Ned Sharpless addressed his agency on Tuesday for the first time and promised to focus on improving their work environment. Read More
Canadian regulators on Tuesday laid out guidance that they hope will help sponsors use real-world evidence to speed life-saving drugs to those who need them most. Read More
The Supreme Court has scotched Allergan’s attempt to hide a patent for one of its blockbuster drugs in a Native Tribe’s reservation—but the case is only different in degree from what has become common practice in the drug industry, a legal expert tells FDAnews. Read More
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The Senate will weigh another three bills aimed at lowering drug prices in what is turning out to be a frenetic session for the drug industry. Read More
The investigator also found that the firm didn’t conduct dynamic smoke studies for all equipment and components to prove the air flow patterns of critical areas. Read More